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OpenTrials
Completed

NCT Number: NCT02844179

(+)-Alpha-Dihydrotetrabenazine Phase I

This research study is intended to determine the initial safety and tolerability of single oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ, the drug to be studied in this research, is the active ingredient in TBZ. The present study will confirm safety and tolerability of HTBZ and will investigate its expected effects on brain sites that are the target of TBZ therapy.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan hospitals

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • able to provide informed consent

Exclusion criteria

  • pregnant or lactating female subjects
  • Subjects taking medications that interfere with VMAT2 (ex amphetamine)
  • History of significant neurologic or psychiatric conditions
  • Significant active medical conditions
  • Alcohol or illicit substance use or dependence

Treatment and study plan

HTBZ

Drug

Primary outcomes

  1. VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning

    Time frame: 60 minutes post-administration of HTBZ

Sponsors and collaborators

Lead sponsor

Kirk A. Frey

Other

Collaborators

  • Adeptio Pharmaceuticals

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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